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Completed

NCT Number: NCT03996291

Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 1240003, Vancouver, British Columbia, Canada

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About this study

Approximately 62 months including the 8 weeks post-treatment visit

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants had to have completed treatment in the DRI15928 study
  • Female participants had to continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (FSH) level >30 UI/L.
  • The participant had to have given written informed consent prior to undertaking any study related procedure.

Exclusion criteria

  • The participant had a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
  • The participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study.
  • The participant had received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing treatment with SAR442168. Washout periods after treatment with non-study DMTs had to be respected except for interferons or glatiramer acetate treatment.
  • The participant was receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
  • The participant was receiving anticoagulant/antiplatelet therapies, including:
  • Acetylsalicylic acid (aspirin)
  • Antiplatelet drugs (eg, clopidogrel)
  • Warfarin (vitamin K antagonist)
  • Heparin, including low molecular weight heparin (antithrombin agents)
  • Dabigatran (direct thrombin inhibitor)
  • Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)

Note: All above drugs needed to be stopped at least 5 half-lives before study drug administration except for aspirin, which needed to be stopped at least 8 days beforehand.

  • Prior/concurrent clinical study experience. The participant was taking part in another interventional clinical trial of another drug substance.
  • Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures
  • The participant was pregnant or was a breastfeeding woman.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Tolebrutinib

Drug

Pharmaceutical form: Film coated tablet Route of administration: Oral

Other names: SAR442168

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: From first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the respective on-treatment periods.

Secondary outcomes

  1. Mean Number of New Gadolinium (Gd)-Enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192

    Time frame: Weeks 192 and 240

    Magnetic resonance imaging (MRI) of the brain was performed to identify number of new Gd-enhancing T1-hyperintense lesions. Central review was used to identify new Gd-enhancing T1-hyperintense lesions not present at the previous MRI. mITT=modified intent-to-treat; SAP= statistical analysis plan. Only those participants with data collected at specified timepoints are reported.

  2. Mean Number of New or Enlarging T2 Lesions at Week 240 Relative to Week 192

    Time frame: Weeks 192 and 240

    MRI of the brain was performed to identify number of new or enlarging T2 lesions. Central review was used to identify new or enlarging T2 lesions not present at the previous MRI; the values were standardized to per month values by dividing by the number of months (4-week intervals) from the previous MRI to the current MRI.

  3. Total Mean Number of Gd-enhancing T1-hyperintense Lesions at Week 240 Relative to Week 192

    Time frame: Weeks 192 and 240

    MRI of the brain was performed to identify number of Gd-enhancing T1-hyperintense lesions. Central review was used to identify Gd-enhancing T1-hyperintense lesions not present at the previous MRI.

  4. Annualized Relapse Rate (ARR)

    Time frame: From Baseline (enrollment in LTS16004, Day 1) to Week 240

    Multiple sclerosis (MS) relapse was defined as acute, new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Symptoms were attributable to MS, lasted for >=24 hours with or without recovery, present at normal body temperature and preceded by >=30 days of clinical stability. ARR was the total number of relapses for participants by dose group divided by the sum of the standardized study duration for participants in the dose group.

  5. Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 240

    Time frame: Baseline (Day 1 of DRI15928) and Week 240

    The EDSS is a disability scale that assesses the following 7 functional domains: visual, brainstem, pyramidal (motor), cerebellar (coordination), sensory, cerebral, and bowel/bladder. The total EDSS ranges from 0 (normal) to 10 (death due to MS) (0.5 increments from 1-10; next increase after 0 is 1). Higher scores indicated increased disability. Baseline assessed for long-term tolebrutinib treatment by change from baseline was defined as the last non-missing value prior to the first administration of randomized study drug in DRI15928 study.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2019
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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